Archimedes Pharma Enrols first patient in Phase III programme for Nasalfent
European specialty pharmaceutical company Archimedes Pharma has commenced its global Phase III programme for Nasalfent in breakthrough cancer pain.
European specialty pharmaceutical company Archimedes Pharma has commenced its global Phase III programme for Nasalfent in breakthrough cancer pain.
Up to 180 patients are being recruited in a placebo-controlled, randomised trial across 43 centres in the US and Canada. The endpoints will focus on assessments of pain intensity and pain relief at several time points up to 60 minutes post treatment and will provide data on the acceptability and safety of Nasalfent. Patients who successfully complete the trial will be eligible to enrol in a longer-term open safety study.
Nasalfent is an innovative fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain. Patients suffering from breakthrough cancer pain may have very limited treatment options. Fentanyl is a highly effective opiate analgesic and is seen as the drug of choice for breakthrough cancer pain because of its rapid onset and short duration of action.
Nasalfent incorporates Archimedes' proprietary PecSys nasal drug delivery system, an enabling technology that modulates the flow of molecules across mucosal membranes. When used in intranasal drug delivery the technology offers the potential to optimise the profile of molecules and with Nasalfent facilitates fast absorption ad rapid onset of pain relief but controls the amount of fentanyl absorbed to minimise side effects.
'There continues to be substantial unmet clinical need in the treatment of this condition, part of which presumably relates to a mismatch between the quick onset of most pains and the time-action relationships of oral therapies,' said lead investigator Dr Russell K. Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center, New York, and one of the world's leading authorities on breakthrough cancer pain. 'An opioid formulation that has a rapid onset of effect, and is safe and effective, will address this unmet need.'